With CBD, marijuana-based medicine gets its first greenlight from the FDA

FDA approves first cannabis-based drug

FDA approves first cannabis-based drug

In one study of 120 children and young adults with Dravet syndrome, cannabidiol reduced the median frequency of convulsive seizures to 5.9 a month from 12.4 before treatment, while patients getting a placebo saw minimal reductions, according to results published previous year in the New England Journal of Medicine.

According to Dr. Angel Hernandez, of the Helen DeVos Children's Hospital in Grand Rapids, Mich., these results prove that pharmaceutical-grade CBD helps suppress seizures and "increases our options to treat many of these patients with very, very difficult-to-control epilepsies".

Called Epidiolex, the drug is created to treat two rare forms of childhood epilepsy using a cannabis compound called cannabidiol (or CBD).

He added, "This is how sound medical science is advanced".

"In my practice, I often see patients with these highly treatment-resistant epilepsies who have tried and failed existing therapies and are asking about CBD", Devinsky said. The British drugmaker studied the drug in more than 500 patients with hard-to-treat seizures, overcoming numerous legal hurdles to conducting research with cannabis. Cannabis-derived CBD products are available where recreational marijuana is sold, though CBD derived from industrial hemp faces fewer regulations and is even stocked by some grocery stores.

Now with the approval of Epidiolex, a drug that will not produce an euphoric "high" feeling in the user - Devinsky said he expected CBD would be moved down to a schedule 4 or 5 drug, which is one that poses a low potential for abuse and dependence. Shinnar said he will welcome approval of a medicine that had undergone stringent FDA review for safety and effectiveness. It's just a gray area, and many are erring on the side of caution and not doing business in those states.

Carson says he will likely prescribe Epidiolex going forward.

CBD oil is now sold online and in specialty shops across the USA, though its legal status remains murky. Agency officials paved the way for the cannabis-based drug by defending its effects in a briefing document, writing, "In general, the risks associated with CBD treatment appear acceptable, particularly given the findings of clinical efficacy in LGS and DS, which are serious, debilitating, and life-threatening disorders". "There's no time line or clock that starts ticking on us". Only products that have received formal FDA approval can make such claims, typically requiring clinical trials costing millions.

Justin Gover, chief executive officer of GW Pharmaceuticals, described the approval in the statement as "a historic milestone".

GW Pharma grows its own supply of cannabis in specialized glass houses in the United Kingdom to ensure uniformity in the genetic composition of the plants, which are then processed into a liquid solution of CBD.

Still, this approval comes as the White House is said to be reconsidering federal prohibition of marijuana and as more and more states approve it for recreational and medicinal use.

"For a maligned substance like cannabis, I think the vindication tour will ultimately be years long", said Ricardo Baca, a former marijuana editor at the Denver Post, and the founder of Grasslands, a cannabis PR agency.

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